Accumulators, cannabinoids & opioids (Intrigued? Keep reading!)

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Happy Monday, readers!

While we’re busy celebrating Earth Day by eating local, non-bagged lettuces and reading and recycling newspapers, we also caught up on breaking news in healthcare headlines:

Cannabinoid get a “thumbs up” just in time for 4/20. In a coincidental twist of scheduling fate, an FDA advisory committee gave the thumbs up to an investigational form of cannabinoid the day before 4/20. But lovers of recreational herbal remedies should not be confused. The yet-to-be-approved medicine is specially formulated to prevent the euphoria associated with marijuana. The move comes as forms of medical marijuana have increasingly been legalized in some states. The times seemingly are a-changin’!

Going on offense on OUD. Speaking of Commissioner Gottlieb, he’s been pretty busy: Last week, Gottlieb issued a statement on steps to encourage more innovation of new treatments for opioid use disorder (OUD). Additionally, the FDA issued new draft guidance on drug development and clinical trial design on buprenorphine “depot” products for medication-assisted treatment (MATs).

And we wouldn’t be The Week That Was without have a thing or two to say about drug pricing:

POTUS and drug prices. The worst-kept secret in Washington – otherwise known as the President’s plans to address drug pricing – is delayed, according to Politico. The speculated policies were rumored to not be too onerous to pharma, while still fulfilling the President’s promise to address drug pricing. POTUS’s delayed press conference comes on the heels of a new report that found net spending on all prescription medicines grew <1% in 2017.

Accumulators: Our very own Peter Pitts spoke to STAT about copay accumulators, new tools used by insurance companies to not count the value of copay assistance coupons toward patient deductibles. Why do accumulators matter? Because not counting these coupons means patients feel a greater burden of their deductible costs, which could lead to lower compliance rates to medicines. Call us if you want to talk about what it means to your brand.

Okay! That was a lot. Now, read on for The Week That Was …

►ULTRAGENYX: HOME RUN OR GRAND SLAM?

Ultragenyx received approval Tuesday afternoon for Crysvita, the first medicine indicated for the treatment of X-linked hypophosphatemia (XLH), a rare inherited form of rickets. And like most biopharms, it disclosed its price the day of approval – which came in about 30% higher than analysts expected. When most companies price higher than marketplace expectations, they get dinged. But, the markethasn’t balked at Ultragenyx. In fact, several analysts, reporters, and even Steve Miller of Express Scrips cite its “reasonable” and “lower end” of rare disease drug pricing. So what did Ultragenyx, do differently? For starters, it disclosed the net price on its approval investor call (vs. the list price), which is what the company expects after discounts and rebates to payers. In fact, Ultragenyz stated the net price would be 35 percent less for adult patients – though it stopped short of expressing some of the nuanced details behind the discounts.

OUR TAKE

We’ve handled a lot of price disclosures for new drug approvals (~20% of all drugs approved in the last year) and would consider this one a home run...but not quite a grand slam. With complicated pricing that varies based on body weight, Ultragenyx managed to recruit validators to support pricing in the media. It also communicated about the rarity of disease, unmet needs and plans for a patient assistance program. For developers approaching commercialization: remember that drug approvals are an opportunity to start communicating to a community broader than investors. To truly hit it out of the park, elevate patient access information and outcomes stories to help ensure that patients are central to the approval story line.

►HAS GLAXO LOST IN TRANSLATION?

GlaxoSmithKline is facing lawsuit by Armenians who couldn’t understand warnings that Avandia, the company’s diabetes drug, could cause serious heart conditions. A California state appeals court has reinstated a 2011 lawsuit brought by four people who cannot read or speak English claiming that this prevented them from learning the risks. The court originally ruled that there was sufficient publically available information (Glaxo revised Avandia’s label in 2007 and there was widespread publicity). However, in an appeal, the plaintiffs argued that Glaxo never considered that they did not have access to the English-language media that carried the warnings.

OUR TAKE

No, we don’t believe that pharmacos need to translate all warnings into 350 languages. However, some communications go beyond words. Warnings to consumers can and should include easy-to-understand messages that can be easily deciphered. Whether or not the courts decide that pharmacos need to issue warnings in other languages, good communicators know that challenging messages are often best delivered along with images that capture individuals’ attention. We often advise our clients that any complex message should be accompanied with infograms or visuals to help tell the story. In fact, heed this advice for most patient communications including access messages and complex indication or dosing information. Sometimes a picture is truly worth a thousand words.